The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to strict regulatory safety standards and finding flexibility to make advances. In my opinion, regulatory agencies should take steps to…   Read more»

A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for continuously updating goals as they change and communication with stakeholders. At the start of a project, the PM…   Read more»

When it comes to working within a team virtually, I find that the best way to effectively communicate is finding the right platform and giving everyone enough time to engage. The first aspect of team communication is choosing a platform…   Read more»

In my opinion, a balanced combination of in-person and virtual communication can be used in successful project management. I do not think it necessary to go all in on either method of communication, but to acknowledge the benefits to each….   Read more»

Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediate agreement or quick decision is required. Companies use a variety of strategies to ensure that verbal…   Read more»

To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and working closely with healthcare stakeholders. One approach is focusing on patient outcomes by developing products that demonstrate obvious clinical benefits, including…   Read more»

Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture related to a hypothetical heart implant company: Risk avoidance: A company is developing a heart…   Read more»

There are ISO and FDA standards that frame how risk management should be handled when it comes to medical devices. According to ISO 14971, risk analysis should include identifying potential hazards and estimate associated risks, risk control should include implementing…   Read more»

When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance between strict regulatory compliance and the company’s operational needs, and choices can vary depending on the company’s goals. Some…   Read more»

Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs. Although they are different, there are situations where these processes can be…   Read more»

Customer feedback is very important to the design input process because it drives user needs. In some cases, feedback can be ambiguous and cause challenges in translating the designs into reality. Some ways that design teams can handle this are…   Read more»

It is possible that teams log additional design inputs beyond the requirements for different reasons, including predictive measures, future risk prevention, or preparing for later iterations of the product. The goal is typically to meet the essential inputs for verification…   Read more»

A DHF can become overwhelming if not managed correctly. Some ways to mitigate this are to organize the DHF by development phase to make it easy for any reader to follow the development process, group together similar types of documents…   Read more»

Validation processes such as testing and verification are if utmost importance to product development across all industries. In my experience, these processes play a crucial role in identifying defects early, confirming the product meets user requirements, and building confidence in…   Read more»

In clinical trials, effective communication among sponsors, investigators, CROs, and IRBs is crucial when handling unexpected adverse events. I believe that it would be beneficial to have a standardized, predefined process for addressing unexpected adverse events, but there is also…   Read more»

I think in most cases it is appropriate to offer patients in a clinical trial payment for their participation. Being involved in a clinical trial often involves time and travel of being treated and coming back for check-ups, which can…   Read more»

There are many ethical issues that could arise when using AI in clinical trials. When it comes to selection of participants, it is possible for AI systems to unintentionally show bias based on the data that was used to train…   Read more»

In the medical device industry, the emphasis on trust and long-term relationships is critical. It is the role of a good sales representative to build this long-term trust by providing quality service and personalized support. Besides gift giving and taking…   Read more»

Story telling is an effective strategy for brands to create customer loyalty because it is a way for them to connect with their customers on a personal level. I know that I have definitely fallen victim to these types of…   Read more»

Customer retention is an extremely important aspect of running a successful business. Some strategies that businesses can use to for customer retention include personalized communication, being receptive to feedback, and overall excellent customer service. Businesses should strive to make each…   Read more»